Traditional sample systems for pharmaceutical or biopharmaceutical processes use large stainless steel systems that include steam traps and the like to at least aseptically clean the system between uses.
U.S. Pat. No. 6,032,543 introduced a disposable sterile sampling system comprised of a carousel or holder into which one or more septum containing sampling collection devices are attached. This is sold as the NovaSeptum® sampling device available from Millipore Corporation of Billerica, Mass. The devices have a sample taking device, in this instance a septum surrounding a needle at the front end with the rear portion of the needle being attached to a flexible conduit such as a tube or hose which in turn is attached to a sample storage device such as a bag as shown in the patent or as a syringe as described in US 2006/0211995 A1 and sold as the NovaSeptum® AV system by Millipore Corporation of Billerica. Mass. The internal area between the septum and sample storage device, in the first instance a bag and in the syringe its inner volume, is isolated from the environment and sterilized (gamma or beta radiation, ETO, etc) before assembly into a holder. The holder is liquid tightly attached to a port of a bioreactor or other piece of equipment such as a storage vessel, mixing vessel and the like, the septum based sample taking devices are loaded into the holder and then the face of the system (holder and septum of the sample taking device) is sterilized along with the rest of the interior of the equipment. The vessel is then filled and samples are taken as needed during processing. Information concerning the sample, when and where it was taken and by whom is recorded by hand either onto a paper label that is then attached to the sample storage device or in a notebook.
US 2005/0132821A1 and US2006/0201263A1 add to this concept by eliminating the need for a septum and yet provide a sterile connection and sample collection system. The use of shafts mounted in a holder with tubes connected to the rear portions of the shafts which in turn are connected to s sample storage device such as bags. The shafts are mounted in the holder or body and isolated from the environment and then sterilized by radiation such as gamma or beta, steam, ETO or the like.
US 2006/0272432A1 is also a septum-less system that uses slidable gates to selectively open or close a pathway from the vessel to a conduit and then to a sample storage device.
All of these systems are then mounted to a port and the face of the port is sterilized with the interior of the vessel to provide a sterile pathway for the samples. The shafts are moved either linearly or rotationally into alignment to draw a sample or the gates are moved linearly to open a passage for the liquid sample. As with the NovaSeptum design discussed above, the information is recorded separately and then attached to the sample holder or placed in a notebook.
What is needed is a better method and device for tracking such information in a foolproof manner.